Sundt™ NL81064S01

GUDID 10381780072188

SUNDT EXT. CAROTID ENDARTER SHU. The Integra Sundt external carotid endartecrectomy shunt is designed to provide temporary carotid bypass for cerebral circulation during carotid endarterectomy procedures. The shunts are constructed of silicone elastomer with stainless steel spring reinforcement to minimize kinking and occlusion of the cannula lumen and to aid in the ease of insertion of the proximal and distal ends. The ends of the shunts have cone-shaped bulbs to facilitate fixation of the shunt in the vessel.

Integra Lifesciences Corporation

Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt

• Primary Device ID: 10381780072188
• NIH Device Record Key: fd276263-cbe7-48ac-91a4-2fb07418fe07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sundt™
• Version Model Number: NL81064S01
• Catalog Number: NL81064S01
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072188 [Primary]
HIBCC	M269NL81064S011 [Secondary]

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-08-28
• Device Publish Date: 2015-09-22

On-Brand Devices [Sundt™]

• 10381780072508: One external carotid endarectomy shunt, 30cm non-reinforced segment and a 12cm venting arm with
• 10381780072188: SUNDT EXT. CAROTID ENDARTER SHU. The Integra Sundt external carotid endartecrectomy shunt is des
• M269NL85050791: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050631: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050621: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050611: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050601: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050781: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050771: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050761: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050721: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050711: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050701: Sundt™ External Carotid Endarterectomy Shunt is designed to allow formation of an external loo
• M269NL85050671: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050661: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and
• M269NL85050651: Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and